FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
The FDA has accepted Roche's new drug application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer following prior endocrine therapy, with a decision expected by December 18, 2026.
New research reveals that over a quarter of healthy years lost to breast cancer are linked to modifiable lifestyle factors, while scientists advance targeted therapies and identify cellular mechanisms behind postpartum breast cancer risk.
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
Greenwich LifeSciences announced acceptance of two abstracts for presentation at the AACR Annual Meeting 2026, including the first abstract co-authored with the full FLAMINGO-01 Steering Committee. The conference will be held April 17-22, 2026.
The FDA has granted fast track designation to ART6043 plus olaparib for germline BRCA-mutated HER2-negative breast cancer and to BriaCell's Bria-IMT plus immune checkpoint inhibitor for metastatic breast cancer, both addressing significant unmet medical needs.
The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07599618 |
Evaluation of a Patient-Centered Decision-Making Support Tool for Older Adults With Advanced Breast Cancer and Their Care Partners |
NOT_YET_RECRUITING | NA |
| NCT07593820 |
A Phase I Interventional Open-label, Non-randomized Dose-escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Anti-tumor Activity of Autologous p95HER2.CAR-TECH2Me T Cells in Patients With Selected Advanced Cancers. |
RECRUITING | PHASE1 |
| NCT07593196 |
HER2-positive Metastatic Breast Cancer in Kazakhstan |
NOT_YET_RECRUITING | |
| NCT07582887 |
Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response |
RECRUITING | |
| NCT07580833 |
A Study to Investigate the Effect of Food on the Bioavailability of Oral Paclitaxel Administered With Encequidar in Participants With Advanced Solid Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT07578415 |
Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01) |
NOT_YET_RECRUITING | NA |
| NCT07524855 |
A Study of HLD-0117 in Patients With Metastatic Breast Cancer |
RECRUITING | PHASE1 |
| NCT07519200 |
Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention |
NOT_YET_RECRUITING | NA |
| NCT07512271 |
Generative AI Patient Education Module for Breast Oncology |
NOT_YET_RECRUITING | NA |
| NCT07487844 |
Pulsed Electric Field Ablation for Metastatic Breast Cancer |
NOT_YET_RECRUITING | NA |
